Vaginal or Laparoscopic Hysterectomy, Persistent Postsurg... | NCT01537731

Studies
Vaginal or Laparoscopic Hysterectomy, Persistent Postsurgical Pain

NCT01537731

Sponsor

Tampere University Hospital

Status

Completed

Last Update Posted

Oct 9, 2013Estimated

Enrollment

225Estimated

Phase

Not provided

Conditions

Chronic Postsurgical Pain

Interventions

vaginal or laparoscopic hysterectomy

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Jan 10, 2012

First Submission Date that Met QC Criteria

Feb 22, 2012

First Posted Date

Feb 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2013

Last Update Posted Date

Oct 9, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Previous studies have shown that chronic pain after hysterectomy is common. The aim of this study is to investigate the incidence of chronic pain after vaginal or laparoscopic hysterectomy for benign reasons. The aim of this prospective study is also to study the role of anesthetics, surgery and other possible predictors for pain 6 months after hysterectomy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

225Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hysterectomy		Patient who previously underwent vaginal or laparoscopic hysterectomy	Procedure: vaginal or laparoscopic hysterectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vaginal or laparoscopic hysterectomy	Procedure	vaginal hysterectomy or laparoscopic hysterectomy	hysterectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of persistent postsurgical pain as measured at 6 months after surgery.		five years

Secondary Outcomes

Measure	Description	Time Frame
Severity, location, characteristics of persistent postsurgical pain.		five years
Effect of postsurgical pain on activity, sleep.		five years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who undergo vaginal or laparoscopic hysterectomy for benign conditions
Age 18-69 years
Gender: female
ASA status 1-3

Exclusion Criteria:

Body Mass Index over 35
Diabetes mellitus
Liver disease
Preoperative use of opioids

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Women who undergo vaginal or laparoscopic hysterectomy for benign conditions.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University Hospital		Tampere		33521	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26258656	Derived	Pokkinen SM, Nieminen K, Yli-Hankala A, Kalliomaki ML. Persistent posthysterectomy pain: A prospective, observational study. Eur J Anaesthesiol. 2015 Oct;32(10):718-24. doi: 10.1097/EJA.0000000000000318.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain